A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title: A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease

Status Recruiting

Clinical Trial Summary

This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks.

Clinical Trial Description

Participants will be randomized 1:1 to receive suvecaltamide or placebo and stratified by the Essential Tremor Rating Scale (TETRAS) composite outcome score (≤ 17 or > 17) as assessed at baseline. The maximum total duration of the study for each participant will be 23 weeks, with a maximum treatment duration of 17 weeks. For each participant, the study consists of a Screening Period (up to 4 weeks), a 5-week Dose Titration and Optimization Period, a 12-week Maintenance Period, and a 2-week Safety Follow-up Period. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Tremor

• NCT number: NCT05642442
• Study type: Interventional
• Source: Jazz Pharmaceuticals
• Contact: Clinical Trial Disclosure & Transparency
• Phone: 215-832-3750
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Completion date: December 31, 2024